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为探讨 pH 依赖型梯度释药麝香保心微丸在正常人体内的转运和崩解情况,采用γ-闪烁显像示踪法对6名健康志愿者服用核素标记的微丸进行体内示踪观察。结果表明,HPMC 包衣微丸在胃中崩解,Eu-dragit L-30D-55包衣微丸在十二指肠崩解,而 Eudragit L/S100包衣微丸在空回肠部崩解:禁食状态下微丸在胃和小肠的转运的时间约为5 h,标准餐后约为6 h;微丸在到达回盲部前已完全崩解。结论:pH 依赖型梯度释药麝香保心微丸在人体内具有 pH 依赖型梯度崩解溶散的特征,预计该制剂12 h 服药一次是可行的。
In order to investigate the transport and disintegration of pH-dependent gradient-dispersed Qixiangbaoxin Pellets in normal humans, gamma-scintigraphic imaging was used to trace the radiolabeled pellets in 6 healthy volunteers. Observed. The results showed that HPMC coated pellets disintegrated in the stomach, Eu-dragit L-30D-55 coated pellets disintegrated in the duodenum, and Eudragit L/S100 coated pellets disintegrated in the ileum: The fasting time of the pellets in the stomach and small intestine was about 5 h, and about 6 h after the standard meal; the pellets had completely disintegrated before reaching the ileocecal region. Conclusion: The pH-dependent gradient release Musk Baoxin Pellets has the characteristics of pH-dependent gradient disintegration and dissolution in the human body. It is expected that the preparation will be available once in 12 hours.